Effects of Medications in Patients With Hypogonadism

Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01601327

Enrollment

119

Registered

2012-05-18

Start date

2008-01-31

Completion date

2012-03-31

Last updated

2012-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Keywords

hypogonadism, treatment, testis volume

Brief summary

The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).

Interventions

DRUGTestosterone enanthate (Sustanon 250 mg)

Twenty-eight patients were treated with testosterone enanthate (TE),

DRUGHuman chorionic gonadotropin (hCG) (Pregnyl 5000 IU)

twenty-five patients were treated with human chorionic gonadotropin (hCG)

DRUGTestosteron gel (Testojel 50 mg)

Twenty-four patients were treated with testosterone gel (TG).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

hypogonadotropic hypogonadism * decreased serum testosterone concentration below the normal range (serum T \< 300ng/dL), * FSH and LH levels within or below the normal range, * absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, * normal smell test and normal karyotypes

Exclusion criteria

* previous androgen treatment, * history of smoking, * presence of bilateral anorchia, * intellectual deficiency, * diabetes mellitus, * arterial hypertension or dyslipoproteinemia, * medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded. Participants with iron, vitamin B12 or folate deficiency were also excluded.

Design outcomes

Primary

Measure	Time frame
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.	3 years
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.	3 years
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.	3 years

Secondary

Measure	Time frame
Effect of testosterone enanthate on testis volumes	3 years
Effect of testosterone gel on testis volumes	3 years
Effect of human chorionic gonadotrophin on testis volumes	3 years

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026